DepressionNCT00393536
Study of Whether Educational Visits to Primary Care Professionals Improves the Quality of Care They Provide.
A study testing Educational outreach visiting in people with Depression, run by Newcastle University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to find out whether educational visits by Pharmacists, who are already employed as advisers in health organisations, improve the prescribing habits of primary care doctors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression
- What is being tested?
- Educational outreach visiting
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 73 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 1999to Dec 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all general practices in Newcastle and North Tyneside, England
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Health and Society
Newcastle upon Tyne, Tyne and Wear, NE2 4AA
About this study
Official title: A Pragmatic Randomized Controlled Trial of Untargeted Educational Outreach Visiting Delivered by Pharmaceutical Advisers in Primary Care.
The purpose of this study is to find out whether educational visits by Pharmacists, who are already employed as advisers in health organisations, improve the prescribing habits of primary care doctors.
Read the detailed description
Background There is increasing evidence that clinical guidelines can lead to improvements in both the process and outcome of care[1]. They figure prominently within the UK, particularly since the inception of the Scottish Intercollegiate Guidelines Network (SIGN) and the National Institute for Health and Clinical Excellence (NICE). However, clinical guidelines are not self-implementing and there is a growing body of research that demonstrates the effectiveness of various implementation strategies[1]. This has suggested that while the commonly used strategy of the postal distribution of educational materials alone may change clinician's behaviour it is unlikely to lead to large changes in practice. Educational outreach visits, using a trained person to meet face-to-face with a health care professional to provide information, may improve practice, especially prescribing behaviour[1,2]. Previous studies of the effectiveness of outreach visiting in the UK NHS have used local pharmacists as the visitors[3,4]. All Primary Care Trusts (PCTs) in England employ Pharmaceutical Advisers who are pharmacists whose role is to provide, from a wide clinical and health service management perspective, advice on prescribing and related areas to general practitioners (GPs). Pharmaceutical Advisers routinely visit general practices and are seen as change agents; however, the formal delivery of educational outreach by them has not been evaluated.
In 1996, the then Newcastle and North Tyneside Health Authority established a Clinical Effectiveness Unit. The remit of the Unit was to provide support to local health care teams in primary and secondary care, with the aim of promoting clinical effectiveness and encouraging the use of best evidence in daily practice through systematic, evidence-based approaches to guideline implementation. The strategy adopted by the Clinical Effectiveness Unit was to concentrate on five clinical areas. These were selected by a multi-disciplinary steering group using explicit criteria (evidence of inappropriate variation in practice; a good evidence base for what should be done; the clinical area should be a source of significant morbidity or mortality; large cost implications in the management of the topic). Depression was one of the clinical areas chosen.
The aim of this study was, for the choice of antidepressants for the management of depression, to evaluate, within a pragmatic cluster randomized controlled trial, the effectiveness of outreach visiting by existing Pharmaceutical Advisers in addition to the postal distribution of educational materials.
Methods Within a pragmatic randomized controlled trial, involving all general practices in two PCTs, routine methods were used to distribute guidelines for the choice of antidepressants for the management of depression. Intervention practices were offered two visits (most accepted only one) by their PCT Pharmaceutical Adviser who had been trained in the techniques of outreach visiting. The intervention was evaluated using level three Prescribing Analysis and Cost (PACT) data for antidepressant drugs for the six months during which the intervention was delivered and the subsequent 12 months
- Conditions
- Depression
- Being tested
- Educational outreach visiting
- Keywords
- Depression, Guidelines, Educational outreach visiting, Prescribing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational outreach visitingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of antidepressant drugs by type
Secondary outcomes (1)
Costs of antidepressant drugs by type
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2006 (estimated)
- Study startJul 1999
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Investigators
- Martin P Eccles, MD, Principal investigator, University of Newcastle Upon-Tyne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393536
- Sponsor's protocol ID
- UEOVPAPHC-01
- Status last verified
- Oct 2006
- First submitted
- 26 Oct 2006
- Last updated
- 27 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial of Untargeted Educational Outreach Visiting Delivered by Pharmaceutical Advisers in Primary Care.
- ClinicalTrials.gov ID
- NCT00393536
- Acronym / sponsor ID
- UEOVPAPHC-01
- Conditions
- Depression
- Keywords
- Depression, Guidelines, Educational outreach visiting, Prescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- Jul 1999
- Study completion
- Dec 2000
- First posted
- 27 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether educational visits by Pharmacists, who are already employed as advisers in health organisations, improve the prescribing habits of primary care doctors.
Detailed description
Background There is increasing evidence that clinical guidelines can lead to improvements in both the process and outcome of care[1]. They figure prominently within the UK, particularly since the inception of the Scottish Intercollegiate Guidelines Network (SIGN) and the National Institute for Health and Clinical Excellence (NICE). However, clinical guidelines are not self-implementing and there is a growing body of research that demonstrates the effectiveness of various implementation strategies[1]. This has suggested that while the commonly used strategy of the postal distribution of educational materials alone may change clinician's behaviour it is unlikely to lead to large changes in practice. Educational outreach visits, using a trained person to meet face-to-face with a health care professional to provide information, may improve practice, especially prescribing behaviour[1,2]. Previous studies of the effectiveness of outreach visiting in the UK NHS have used local pharmacists as the visitors[3,4]. All Primary Care Trusts (PCTs) in England employ Pharmaceutical Advisers who are pharmacists whose role is to provide, from a wide clinical and health service management perspective, advice on prescribing and related areas to general practitioners (GPs). Pharmaceutical Advisers routinely visit general practices and are seen as change agents; however, the formal delivery of educational outreach by them has not been evaluated.
In 1996, the then Newcastle and North Tyneside Health Authority established a Clinical Effectiveness Unit. The remit of the Unit was to provide support to local health care teams in primary and secondary care, with the aim of promoting clinical effectiveness and encouraging the use of best evidence in daily practice through systematic, evidence-based approaches to guideline implementation. The strategy adopted by the Clinical Effectiveness Unit was to concentrate on five clinical areas. These were selected by a multi-disciplinary steering group using explicit criteria (evidence of inappropriate variation in practice; a good evidence base for what should be done; the clinical area should be a source of significant morbidity or mortality; large cost implications in the management of the topic). Depression was one of the clinical areas chosen.
The aim of this study was, for the choice of antidepressants for the management of depression, to evaluate, within a pragmatic cluster randomized controlled trial, the effectiveness of outreach visiting by existing Pharmaceutical Advisers in addition to the postal distribution of educational materials.
Methods Within a pragmatic randomized controlled trial, involving all general practices in two PCTs, routine methods were used to distribute guidelines for the choice of antidepressants for the management of depression. Intervention practices were offered two visits (most accepted only one) by their PCT Pharmaceutical Adviser who had been trained in the techniques of outreach visiting. The intervention was evaluated using level three Prescribing Analysis and Cost (PACT) data for antidepressant drugs for the six months during which the intervention was delivered and the subsequent 12 months
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all general practices in Newcastle and North Tyneside, England
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational outreach visiting | Behavioural | – |
Primary outcome
Usage of antidepressant drugs by type
1 secondary outcome
Costs of antidepressant drugs by type
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin P Eccles, MD principal investigator
University of Newcastle Upon-Tyne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational outreach visiting in people with Depression, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage of antidepressant drugs by type. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2006.